Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS ADVERSE REACTIONS Application Site Reactions Even though adverse reactions are rare, a very small percentage of patients experience an unpleasant burning sensation, redness, warmth, or stinging.
It is advisable to apply a small amount on the forearm prior to first use.
If any of these effects persists or worsens, contact your physician or pharmacist immediately.
This medication is not absorbed systemically but if any serious side effects (i.e.
rash, itching/swelling, severe dizziness) are experienced, discontinue use immediately and contact your pharmacist or physician.
This is not a complete list of all side effects that may occur.
You may report side effects to the FDA at 800-FDA-1088 or at http://www.fda.gov/medwatch.
Allergic Reactions Allergic and anaphylactoid reactions associated with lidocaine, although rare, can occur.
They are characterized by angioedema, bronchospasm, dermatitis, dyspnea, hypersensitivity, laryngospasm, pruritus, shock, and urticaria.
If they occur, they should be managed by conventional means.
WARNINGS For external use only.
Not for ophthalmic use.
EXCESSIVE DOSING Excessive dosing by applying Lidotral™ 5% with Menthol Spray to larger areas or for longer than the recommended wearing time could result in increased absorption of lidocaine and high blood concentrations, leading to serious adverse effects (see ADVERSE REACTIONS, Systemic Reactions).
Lidocaine toxicity could be expected at lidocaine blood concentrations above 5 mcg/mL.
The blood concentration of lidocaine is determined by the rate of systemic absorption and elimination.
Like all medications, Lidotral Five Percent With Menthol can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: